Trial Outcomes & Findings for Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ) (NCT NCT01395537)

Last Updated: 2019-03-19

Results Overview

A dose limiting toxicity (DLT) will be defined as any grade 3-4 non-hematologic toxicity or increase in bilirubin \>/= 2 mg/dL (\>2X baseline in patients with Gilbert's syndrome), or elevation in AST/ALT \> 3.0 X ULN during the first 3 week course of therapy.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

after 9 weeks (3 cycles) of treatment

Results posted on

2019-03-19

Participant Flow

Participants were recruited from medical clinic from 8/2011 to 4/2013.

Participant milestones

Participant milestones
Measure	Lapatinib With Carboplatin and Paclitaxel Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.
Phase I STARTED	13
Phase I COMPLETED	13
Phase I NOT COMPLETED	0
Phase II STARTED	1
Phase II COMPLETED	1
Phase II NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lapatinib With Carboplatin and Paclitaxel n=13 Participants Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: after 9 weeks (3 cycles) of treatment

Population: All participants that received treatment

Outcome measures

Outcome measures
Measure	Lapatinib With Carboplatin and Paclitaxel n=13 Participants Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.
PHASE I: Number of Patients That Experience a Grade 3-4 Dose Limiting Toxicity	1 Participants

PRIMARY outcome

Timeframe: after 37 months

Population: Participants eligible to move to phase II of study. Study was cancelled prior to additional participants moving to study.

Number of patients with stable or responding disease after 6 cycles of carboplatin and paclitaxel will continue treatment with lapatinib alone until progression of disease or intolerable side effects.

Outcome measures

Outcome measures
Measure	Lapatinib With Carboplatin and Paclitaxel n=1 Participants Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.
PHASE II: To Assess the Response Rate to This Regimen.	0 Participants

SECONDARY outcome

Timeframe: after 37 months

Population: Participants that received treatment

Overall survival is defined as the length of time between the date of starting treatment and death due to any cause. For a patient who is alive at the time of the statistical analysis, the patient will be considered censored at the last date of known contact.

Outcome measures

Outcome measures
Measure	Lapatinib With Carboplatin and Paclitaxel n=13 Participants Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.
To Determine the Overall Survival	32 weeks Interval 15.0 to 75.0

Adverse Events

Lapatinib With Carboplatin and Paclitaxel

Serious events: 4 serious events

Other events: 11 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Lapatinib With Carboplatin and Paclitaxel n=13 participants at risk Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Blood and lymphatic system disorders Febrile neutropenia	15.4% 2/13 • Number of events 2 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Infections and infestations Infections and infestations - Other, specify	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Blood and lymphatic system disorders Neutropenic Fever	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.

Other adverse events

Other adverse events
Measure	Lapatinib With Carboplatin and Paclitaxel n=13 participants at risk Carboplatin AUC: Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. Paclitaxel: Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects. lapatinib: Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.
Skin and subcutaneous tissue disorders Acneiform Rash	7.7% 1/13 • Number of events 2 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Blood and lymphatic system disorders anemia	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Metabolism and nutrition disorders anorexia	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Musculoskeletal and connective tissue disorders Arthalgias	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Gastrointestinal disorders diarrhea	53.8% 7/13 • Number of events 10 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Gastrointestinal disorders dysphagia	46.2% 6/13 • Number of events 8 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
General disorders fatigue	15.4% 2/13 • Number of events 4 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Blood and lymphatic system disorders febrile neutropenia	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Gastrointestinal disorders Gastritis	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
General disorders infusion reaction	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Gastrointestinal disorders mucositis	7.7% 1/13 • Number of events 2 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Gastrointestinal disorders Mucositis/stomatitis	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Musculoskeletal and connective tissue disorders myalgia	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Gastrointestinal disorders nausea	46.2% 6/13 • Number of events 6 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Gastrointestinal disorders Nausea/Vomiting	15.4% 2/13 • Number of events 2 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Nervous system disorders Neuropathy	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Investigations Neutropenia	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Nervous system disorders Numbness	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Nervous system disorders peripheral neuropathy	7.7% 1/13 • Number of events 3 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Investigations platelets, decreased	7.7% 1/13 • Number of events 3 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Skin and subcutaneous tissue disorders rash on nose and chin	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Gastrointestinal disorders right upper quadrant pain	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Skin and subcutaneous tissue disorders Rosacea	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.
Investigations weight loss	7.7% 1/13 • Number of events 1 • Adverse events were collected while participants were on study ranging from 4 to 19 months.

Additional Information

David Adelstein MD

Case Comprehensive Cancer Center

Phone: 216-444-9310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place